Efficacy and tolerance of a new silicone stent for the treatment of benign tracheal stenosis: preliminary results.

STUDY OBJECTIVE In inoperable patients with tracheal stenosis who are treated using silicone stents, stent migration occurs in 18.6% of cases. To decrease the migration rate, we have designed a new silicone stent with narrow central and larger distal parts. This study analyzes the stability and tolerance of this new stent. DESIGN Preliminary prospective study conducted in two French university hospitals. PATIENTS Thirteen inoperable patients with benign complex tracheal stenosis due to intubation or tracheotomy. INTERVENTIONS Tracheal stent insertion was performed under general anesthesia with a rigid bronchoscope. The patients were followed up clinically up to stent removal, which was planned at 18 months. RESULTS Stent insertion or removal was very simple and did not differ from other silicone stents. No migration occurred after a mean follow-up of 22.8 months. Minimal granuloma formation occurred in only one patient (7.7%). Sputum retention remained similar to that with other silicone stents and could be improved by a smoother internal wall. Stents have been removed in seven patients after a mean duration of 19.6 months, with a complete stenosis cure in four cases. CONCLUSION This new stent combines the excellent stability of the metallic stents and the tolerance and easy removal of straight silicone stents. This allows a prolonged use in order to obtain curative action.